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Bethesda,
Maryland20892

Purpose:

This study will compare the effectiveness of two blood thinners, heparin and lepirudin, in
preventing withdrawal occlusion (blockage) in a venous access device (VAD). A VAD is a
catheter (plastic tube) placed in a vein beneath the collarbone to deliver medication and
withdraw blood samples during treatment. The device may become clogged, possibly by
formation of a clot around the tip, blocking its opening and making it difficult or
impossible to use. The clot can be dissolved by a medication called tPA. The blood thinner
heparin has been used for many years to try to prevent the blockage from occurring, but it
is still a problem in as many as 25 percent of VADs. This study will test whether a new
blood thinner called lepirudin is more effective than heparin in preventing withdrawal
occlusion caused by a small clot.
Patients 21 years of age and older who are enrolled in NIH protocols at the Clinical Center
and who require tunneled, open-ended VADs for their medical care may be eligible for this
study. Candidates must expect to receive all of their primary medical care at the Clinical
Center during the first 4 weeks after their VAD is inserted and most of their care at the
Clinical Center for the next 3 months.
Participants will be randomly assigned to receive either heparin or lepirudin flushes for
the first 3 or 4 weeks after placement of their VAD-the period during which withdrawal
occlusion is most likely to occur. After this period, all patients will use routine heparin
flushes until the VAD is removed.
The patient's VAD will be closely monitored for withdrawal occlusion during the 3- to 4-week
test period and will continue to be observed for up to 3 months to check for lasting effects
of the blood thinner.

Study summary:

This protocol tests whether a new anticoagulant, lepirudin, will be superior to heparin in
preventing withdrawal occlusion of tunneled, open-ended venous access devices (VADs). At the
Clinical Center approximately 25% of such VADs develop withdrawal occlusion requiring
treatment with recombinant tissue plasminogen activator (rtPA). Because withdrawal
occlusion is frequently caused by the accumulation of clot at the catheter tip, open-ended
VADs are routinely flushed with heparinized saline. In theory lepirudin should be more
effective in preventing accumulation of fibrin at the catheter tip because it can counteract
the potent clotting enzyme thrombin that is bound in the fibrin, whereas heparin is less
able to do this. In this protocol the assignment of the flush solutions is randomized.
Because most withdrawal occlusion presents within a few weeks of catheter insertion, blinded
flushes of heparin or lepirudin are given at least daily for the first 3 - 4 weeks of
catheterization. Then all VADs begin unblinded routine flushes with heparin. The primary
study endpoint is the number of patients in each group requiring rtPA because of withdrawal
occlusion during the first 4 months after a VAD is inserted. To detect a 50% reduction in
rtPA usage with a one-sided significance criterion of 0.05 and a power of 0.80, 147 patients
will be required in each treatment arm, although the accrual goal is 170 patients per arm to
allow for a small number of unevaluable subjects. Since most tunneled, open-ended VADs at
the Clinical Center are used by patients on bone marrow transplant protocols of the NCI and
NHLBI, these populations will be the primary sources of participants.

Criteria:

INCLUSION CRITERIA:
All patients must:
Be greater than or equal to 18 years old.
Be enrolled in protocols at the Clinical Center.
Require tunneled, open-ended VADs for their primary care.
Have their VADs inserted at the Clinical Center in Interventional Radiology.
Intend to receive the majority of their primary medical care at the Clinical Center during
the first 4 months after their VAD is inserted.
Have serum creatinine less than or equal to 2.5 mg/dL or a glomerular filtration rate
greater than or equal to 50 mL/minute.
Expect to have a platelet count of 70,000/microliter or more without transfusion support
for the first 4 weeks of the study anytime that they are not hospitalized.
Have normal blood coagulation. This is defined by either a prothrombin time and aPTT
within the laboratory's normal range (11.8-14.7 sec and 23.4-34.5 sec respectively), or by
hemostatic coagulation factor levels in patients with prolonged prothrombin times and/or
aPTTs that are explained by mild factor VII deficiencies (30-40 %) or by lupus
anticoagulants. If a patient has a prolonged aPTT due to a lupus anticoagulant, he/she
must have a normal thrombin time in order to be included in the study.
EXCLUSION CRITERIA:
A preference by the primary investigator to use saline flushes for the patient's VAD.
A history of hypersensitivity to heparin, including heparin-induced thrombocytopenia.
(Note that a patient is not excluded simply because he/she has participated in this
protocol with a previous VAD or because he/she still has a previously inserted VAD that
has been left in place.)

NCT ID:

NCT00039767

Primary Contact:

N/A

Backup Contact:

N/A

Location Contact:

Bethesda, Maryland 20892United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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